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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04966039
Other study ID # M2017316
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diffusion weighted imaging (DWI) can reflect the microstructure and pathological changes of tissue, and diffusion tensor imaging (DTI) can quantitatively evaluate the fine structure of white matter in brain. In this study, conventional and diffusion-weighted MRI (DWI, DTI) sequences were used to analyze the brain of monochorionic twin pregnancies with demise of one fetus.


Description:

With the incidence rate of twin pregnancy increasing, the incidence of intrauterine death of twin pregnancies is also rising, which has great impact on the morbidity and mortality of the other fetus, and increases the mortality of fetal survival, premature birth, brain damage and long-term sequela. Therefore, it is necessary to examine the central nervous system of the surviving fetus of twin pregnancy and intrauterine death. When the surviving fetus is complicated with nervous system abnormalities, conventional MRI can generally make a diagnosis. However, some of the surviving fetuses may not find other structural or echo abnormalities on B-mode ultrasonography, and even these fetuses do not find structural or signal abnormalities on routine MRI examination. Whether the surviving fetuses may have brain abnormalities cannot be detected early by the above methods. Diffusion weighted imaging (DWI) can reflect the microstructure and pathological changes of tissue, and diffusion tensor imaging (DTI) can quantitatively evaluate the fine structure of white matter in brain. The present study is to use conventional sequence and diffusion-weighted imaging (DWI, DTI) to analyze the brain of monochorionic twin pregnancies with demise of one fetus, which aims to find the potential brain abnormalities early and provide some guidance for the clinical diagnosis and treatment in the next step.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Twin pregnancy was diagnosed and one fetus died in utero 2. Twin pregnancy with one abnormal fetus 3. Singleton pregnancy with abnormalities outside the fetal brain Exclusion Criteria: 1. Those who can't cooperate with MRI examination, such as those who have metal, claustrophobia or can't insist on scanning. 2. Pregnant women with gestational age less than 20 weeks.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention.
There was no intervention.

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary basic information age baseline
Primary basic information gestational age baseline
Primary basic information uterine height baseline
Primary basic information abdominal circumference baseline
Primary basic information intrauterine death time of one fetus baseline
Primary MRI DWI sequence (ADC value) baseline
Primary MRI DTI sequence (FA value) baseline
Primary MRI conventional sequence baseline
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